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Any examples of other companies submitting federal grant applications for COVID 19 and the response time for approval?
Hopefully, in more broad terms, as a stockpiled therapeutic against other similar viruses as well...
That would roughly equate to $500 million to $1 Billion at that share price if I'm not mistaken?
Per the Polymer Business Roadmap slide in the new presentation, the next step is Customer Qualification, Design Verification, PARTNERSHIP
How much cash is on hand?
We should get some more color on this in the upcoming conferences and shareholder meeting this month.
Anything new the ML interview video that was PR'd?
Is IPIX limited in how many shares they can sell in a day to raise money through their agreement?
Can someone please breakdown the results from the PR?
With our industry and investor conferences likely on hold or rescheduled until later in the year, does anyone know if we have a backup plan to drive interest in the company and our technology?
Anyone have an idea as to the cost of a Phase 2 trial for Ulcerative Colitis/IBD? Presumably they will take this overseas to reduce cost?
Next 10-Q is due in early May, will be VERY curious to see how much money they raised through the COVID related trading activity by then.
Any idea where the likely location(s) of the Phase 2 UC trial will be?
Thank goodness....Here's hoping anyway! Great news.
We're certainly due for an update. Outside of that, you're right in that we have a pretty packed weekly conference/presentation schedule this month starting next week. Hopefully there is some corresponding news to go along with it.
Hopefully the company is selling enough shares to keep them funded and perhaps allow another trial or more development to take place.
Has there been any mention or indication from LWLG as the whether the biggest hurdle for sub 1V is more due to the polymer or the device?
When and if they succeed with the driverless 1V modulator I imagine the Tier-1 companies will throw all remaining caution to the wind and buy this company out. Will be very curious to see their 12 month goals in the next ASM presentation.
Surprised to see that Leo did not have a comment in the PR today.
Lebby and LWLG are certainly in good company in that list of Keynote Speakers. We appear to be the black sheep of this group based on name-brand recognition, but hopefully not for much longer.
I find these points from the S-1 interesting. They specifically note marketing and sales initiatives as included in the intended use of proceeds:
17 days until the next 10-Q is typically out. Is this filing where we will see the value of the upfront payment from Sigma Aldrich? Does this also mean we are likely hoping for a deal prior to then while the value of that SA payment remains undisclosed? Hopefully Locust Walk is earning their keep.
To put it another way, it is only an increase of 0.05
You do realize that the difference is going from 1.0 V to 1.05 V
That is only an increase of 5 hundredths of a V
Reading through the notes from the shareholder meeting, several people mentioned that the company recently learned new and exciting information about Brilacidin - did the company indicate when they might share this information with shareholders, etc, and what indications (OM, IBD, etc) it may have the most impact on?
Well, it would be interesting as AlfaSigma has right of first refusal/negotiation on UC Brilacidin.
I'd be shocked if that was not a mistake as the Novartis PR was all the way back from May 2018. I'd love it if true, but seems like a pretty big leap.
Should be hearing some more about the latest test results this week or early next, right?
What are the next news-worthy items on deck for KBLB at this point?
Thank you, but most folks don't know that. It would be helpful for new people who should have the capacity to go to the corp website for the majority of that info
IMO:
E -> B -> A
Would the MFO want IPIX to complete the additional share count authorization prior to something "juicy" being released?
I think that is likely the purpose of the special shareholders meeting (to answer questions like those you have put forth, in order to layout the case for supporting the increase in shares authorized)
Presumably they are continuing towards executing the definitive agreement with the current suitor and are drumming up interest for their other programs in an effort to quickly trigger a right of first refusal negotiation with this first potential partner.
For anyone watching, any notes would be much appreciated. TIA !
That's a nice slide deck!!! (minus the grammatical mistakes)
Starting to look awfully close to the partnership/design-in stage...
Is anyone aware of whether Europe/EMA has their own version of the FDA's "Breakthrough" designation?
Maybe this, perhaps?
https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines
PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.
Through PRIME, the Agency offers early and proactive support to medicine developers to optimise the generation of robust data on a medicine's benefits and risks and enable accelerated assessment of medicines applications.
This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.
Accelerated assessment
PRIME builds on the existing regulatory framework and tools already available such as scientific advice and accelerated assessment. This means that developers of a medicine that benefitted from PRIME can expect to be eligible for accelerated assessment at the time of application for a marketing authorisation.
Fostering early dialogue
By engaging with medicine developers early on, PRIME is aimed at improving clinical trial designs so that the data generated is suitable for evaluating a marketing-authorisation application.
Early dialogue and scientific advice also ensure that patients only participate in trials designed to provide the data necessary for an application, making the best use of limited resources.
Key benefits for applicants
Once a candidate medicine has been selected for PRIME, the Agency will:
appoint a rapporteur from the Committee for Medicinal Products for Human Use (CHMP) or from the Committee on Advanced Therapies (CAT) in the case of an advanced therapy to provide continuous support and help to build knowledge ahead of a marketing-authorisation application;
organise a kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts, so that they provide guidance on the overall development plan and regulatory strategy;
assign a dedicated contact point;
provide scientific advice at key development milestones, involving additional stakeholders such as health-technology-assessment bodies, to facilitate quicker access for patients to the new medicine;
confirm potential for accelerated assessment at the time of an application for marketing authorisation.
Eligibility criteria
The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. These medicines are considered priority medicines by EMA.
To be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data.
Next dependable news is the 10-Q due in early May. Hope we don't have to wait that long, and hope the reason we don't have to wait is positive. The current situation is dire unfortunately.
So a month ago (2/28) they PR'd that they hope to have the new materials in a testing device within 6 months...
5 more to go, but hey, who's counting!
I imagine once they get the new material in devices and tested successfully, essentially verifying their product road-map is solid for years to come, it's game over for the company (buyout).
Wow is right. I don't think we've ever heard them use stronger words to describe their technology and achievements. Time to load up?